Tremlett, HL 1
Table (E)T-3: Aminotransferase (ALT and AST) elevations split according to IFNB
IFNB / LE / Pre-treatment (³grade 1) / De novo during treatment (³grade 1) / De novo during treatment (³grade2) / De novo during treatment (³grade3) / Total during treatment (³grade 1)IFNB-1b (sc) / ALT / 23/382 (6.0%) / 136/350 (38.9%)*** / 15/350 (4.3%)*** / 4/350 (1.1%) / 189/445 (42.5%)***
AST / 11/397 (2.8%) / 123/375
(32.8%)*** / 12/375
(3.2%)*** / 2/375
(0.5%) / 157/446
(35.2%)***
IFNB-1a (22mcg;sc) / ALT / 11/146 (7.5%) / 43/128 (33.6%)*** / 6/128 (4.7%)* / 2/128 (1.6%) / 61/157 (38.9%)***
AST / 8/149 (5.4%) / 28/134 (20.9%)*** / 2/134 (1.5%) / 1/134 (0.7%) / 39/157 (24.8%)***
IFNB-1a (44mcg;sc) / ALT / 10/141 (7.1%) / 49/129 (38.0%)*** / 10/129 (7.8%)** / 2/129 (1.6%) / 61/152 (40.1%)***
AST / 3/140 (2.1%) / 49/134 (36.6%)*** / 7/134 (5.2%)* / 2/134 (1.5%) / 57/151 (37.7%)***
IFNB-1a(sc)¥ / ALT / 21/287 (7.3%) / 95/257 (37.0%)*** / 17/257 (6.6%)*** / 5/257 (1.9%) / 125/309 (40.5%)***
AST / 11/289 (3.8%) / 80/268 (29.9%)*** / 11/268 (4.1%)** / 4/268 (1.5%) / 99/308 (32.1%)***
IFNB-1a (im) / ALT / 1/55 (1.8%) / 12/52 (23.0%)*** / 1/52
(1.9%) / 0/52 / 13/59 (22.0%)**
AST / 1/58 (1.7%) / 10/55 (18.2%)** / 0/55 / 0/55 / 11/59 (18.6%)**
All IFNBs / ALT / 45/724 (5.3%) / 243/659 (36.9%)*** / 33/659 (5.0%)*** / 9/659 (1.4%)** / 327/813 (40.2%)***
AST / 23/744 (2.7%) / 213/698 (30.5%)*** / 23/698 (3.3%)*** / 6/698 (0.9%)* / 267/813 (32.8%)***
Key: A 2-sided Mc Nemar’s test was used to compare results to baseline (pre-treatment). Significant differences are denoted as: ***(p<0.0005); **(p<0.005); *(p<0.05).
¥ 22 and 44mcg tw groups combined. The combined group includes the full history of patients who may have switched (without interruption) between low and high dose IFNB-1a(sc) and vice versa, therefore in some instances simple addition of the 22mcg and 44mcg groups does not equal the combined figures (¥).
Note: Addition of columns: ‘pre-treatment’ figures + ‘de novo during treatment’ figures ≠ ‘total during treatment;’ as some patients with a missing baseline may have had elevated aminotransferases and hence would only be included in the ‘total during treatment’ column.